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Suvorexant tablets, over-encapsulated
Suvorexant tablets, over-encapsulated is a Small molecule drug developed by Eisai Inc.. It is currently in Phase 1 development. Also known as: BELSOMRA.
Suvorexant tablets are a medication used to treat insomnia disorders. They work by blocking the activity of orexin, a neurotransmitter involved in regulating sleep and wakefulness, as indicated by their mechanism of action in ChEMBL.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Suvorexant tablets, over-encapsulated |
|---|---|
| Also known as | BELSOMRA |
| Sponsor | Eisai Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users (PHASE1)
- Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Suvorexant tablets, over-encapsulated CI brief — competitive landscape report
- Suvorexant tablets, over-encapsulated updates RSS · CI watch RSS
- Eisai Inc. portfolio CI
Frequently asked questions about Suvorexant tablets, over-encapsulated
What is Suvorexant tablets, over-encapsulated?
Who makes Suvorexant tablets, over-encapsulated?
Is Suvorexant tablets, over-encapsulated also known as anything else?
What development phase is Suvorexant tablets, over-encapsulated in?
Related
- Manufacturer: Eisai Inc. — full pipeline
- Also known as: BELSOMRA
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing